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Glaxo plans to prevent diet pill sales to minors

Diedtra Henderson Boston Globe Jan. 14, 2006 12:00 AM

WASHINGTON - Popping a diet pill to fulfill a New Year's resolution to lose weight may become easier this year, but perhaps only for people who can prove they're old enough.

GlaxoSmithKline Consumer Healthcare wants to sell a low dose of its prescription diet pill Xenical over the counter, but purchasers may be asked to flash a driver's license, just as they do to buy cigarettes or alcohol. The sales restriction would allay governmental concern that adolescents could misuse the pill.

The prescription waiver, if approved, would arrive as the nation struggles with a growing obesity epidemic.

Xenical, known generically as orlistat, helped overweight patients lose 5 percent of their baseline weight within four months in a clinical trial led by a University of Kentucky professor. That's roughly the same weight loss achieved by obese patients who spent two years controlling food-portion sizes in a federal study.

A spokesman for GlaxoSmithKline, which markets Xenical in the United States, said it had not been formally asked for a plan to prevent misuse by teenagers if Xenical is sold over the counter. But when federal advisers discuss the Xenical application on Jan. 23, Glaxo will have a plan ready.

"We don't know if this is going to be a requirement," said Brian Jones, a Glaxo spokesman. "If we do have to do it, we intend to have our preparations in place."

Stores are unlikely to use a single approach to monitor purchases. Jones outlined one strategy they could use: When Xenical is rung up at the register, a computer prompt could prod cashiers to ask for proof of age. Until a valid date of birth is entered, the sale cannot be completed.

Some retailers use this technique in handling the over-the-counter sales of GlaxoSmithKline's nicotine-replacement gum Nicorette.

Xenical accounts for less than $100 million in sales annually in the United States, said Zach Wagner, an Edward Jones analyst. Over-the-counter sales of diet pills tallied $637 million in 2004, the latest available data Thursday from Marketdata Enterprises, a Florida market-research firm. Sales of prescription diet drugs were $413 million in 2004.

Eliminating the need for a prescription could help Xenical break through a crowded field of diet remedies.

"It's an effort, obviously, by them to boost sales of the product," Wagner said. "Will it have a substantial impact? It's hard to say."

Many companies are working on a pill to help people lose weight and keep it off. Still, a recent National Institutes of Health study found that swallowing a diet pill is not enough. Obese adults lost the most weight when they combined a diet drug with such lifestyle changes as a more healthful diet and exercise.